GROUPS EXPAND STRATEGY TO HEAD OFF DRUG TRACKING PROGRAM
Wholesalers are scrambling to find a strategy to stop the FDA from implementing a drug tracking rule they say will allow a few large companies to monopolize the market, forcing smaller competitors out of business.
The pedigree rule requires certain manufacturers to have a record of all transactions a drug goes through, from the manufacturing plant to the dispensing pharmacy. As a whole, the companies share the same goal -- stopping the rule from taking effect Dec. 1. However, two separate camps with differing strategies have been formed, with each side promoting their tactics while downplaying the chances the other will be successful.
One group, led by the National Coalition of Pharmaceutical Distributors (NCPD), is seeking an injunction in federal court to stop the implementation. The other group is going the congressional route, contacting lawmakers to seek their assistance.
Smaller wholesalers say the program will ruin their businesses by establishing a requirement they are unable to meet. The problem is that they purchase their products from authorized distributors of record (ADRs), such as AmerisourceBergen, Cardinal Health and McKesson, which are not required to keep pedigrees or provide them to the smaller wholesalers.
The companies also maintain that they will suffer "irreparable harm" if the rule is implemented Dec. 1 because they will not be able to sell the inventory they have already purchased.
Lobbying is a necessary step because the legal argument NCPD is promoting will likely fail, Gary Klein, a partner at DLA Piper, said. Klein, who represents the lobbying coalition, believes that the agency's decision to allow certain companies to avoid the pedigree requirement is not egregious enough to qualify as a violation of the constitutional equal protection clause, as NCPD argues. Their arguments are a "longshot," he said.